# K170409: PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Laser Systems, Inc. (Tmls)
- Decided: Sep 12, 2017 after 214 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894841 (1989). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser, Topcon Medical Laser Systems, Inc. (2013) Summary page 4.

## Indications for use
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is intended for use to perform single-spot photocoagulation in the posterior segment (retina, choroid) and in the anterior segment (iris, trabecular meshwork) as well as pattern-scanning photocoagulation in the non-macular retina of the eye. Single-spot delivery may be performed using a slit lamp biomicroscope or an indirect ophthalmoscope. Pattern delivery may be performed using a slit lamp biomicroscope.

Source page: https://510kreport.com/device/K170409
Methodology: https://510kreport.com/methodology